Stereotactic Radiotherapy Combined With Adebrelimab and TCb (Nab-paclitaxel + Carboplatin) in Neoadjuvant Treatment of TNBC
Phase 2
Recruiting
- Conditions
- Stereotactic RadiotherapyImmunotherapyBreast Cancer
- Interventions
- Registration Number
- NCT06165900
- Lead Sponsor
- Shengjing Hospital
- Brief Summary
This study was an open-label, multicenter, randomized study. It is planned to include 136 patients with stage II-III triple negative breast cancer. Eligible subjects will be randomized to receive either the experimental arm: adebrelimab plus stereotactic radiotherapy followed by adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin) or the control arm: adebrelimab plus nab-paclitaxel + carboplatin.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 136
Inclusion Criteria
- Treatment-naïve breast cancer female patients aged ≥ 18 years and ≤ 75 years;
- Histopathologically confirmed early or locally advanced triple-negative invasive breast cancer according to the latest ASCO/CAP guidelines, meeting the following conditions: (1) pathological type is triple-negative, specifically: ER negative: IHC < 1%, PR negative: IHC < 1%, HER2 negative: IHC 0/1 + or IHC2 + but ISH negative;
- Clinical stage II-III invasive breast cancer with measurable lesions according to RECIST 1.1;
- ECOG score 0-1;
- Able to tolerate preoperative and postoperative adjuvant radiotherapy after assessment by a radiologist;
- Appropriate level of organ function
- Patients voluntarily participate in and sign the informed consent form, are expected to have good compliance and cooperate with the study according to the requirements of the protocol.
Exclusion Criteria
- Patients with metastatic breast cancer or bilateral breast cancer;
- Patients with inflammatory breast cancer or occult breast cancer;
- Patients received any anti-tumor therapy within 12 months before signing the informed consent form, including chemotherapy, targeted therapy, radiotherapy, endocrine therapy, immunotherapy, biological therapy or tumor embolization;
- Patients previously received PD-1/PD-L1 antibody, CTLA-4 antibody, or other treatments against PD-1/PD-L1 inhibitors;
- Female patients who are pregnant and lactating, female patients who are fertile and have a positive baseline pregnancy test, or female patients of childbearing age who are unwilling to take effective contraceptive measures throughout the trial.
- Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia, and the subject has a known history of psychotropic drug abuse, alcoholism ;
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); positive hepatitis B surface antigen (HBsAg) test, or positive hepatitis B core antibody (HBcAb) test followed by positive HBV-DNA test (HBV-DNA test was performed only in patients with negative HBsAg test and positive HBcAb test); positive hepatitis C virus (HCV) antibody test followed by positive HCV-RNA test (HCV-RNA test was performed only in patients with positive HCV antibody test)
- Any other condition that, in the opinion of the investigator, would make the patient inappropriate for participation in this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description adebrelimab plus stereotactic radiotherapy and chemotherapy adebrelimab plus stereotactic radiotherapy followed by adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin) - adebrelimab plus nab-paclitaxel + carboplatin adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin) -
- Primary Outcome Measures
Name Time Method tpCR 6 months total pathologic complete response
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Shengjing Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China